DRUG
pramlintide acetate
single subcutaneous doses of 15mcg and 30mcg
A Study to Evaluate Symlin in Adolescent Subjects With Type 1 Diabetes Mellitus
Status
Completed
Phase
Phase 2
Enrollment
12
Locations
3
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
This study will be the first evaluation of Symlin in adolescent subjects with type 1 diabetes mellitus and is designed to evaluate the blood levels (pharmacokinetics), biochemical and physiological effects (pharmacodynamics), and safety and tolerability of Symlin in these subjects.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Apr 12, 2006
Study start
Apr 2006
Primary completion
Aug 2007
Study completion
Aug 2007
Results posted
Not reported
Registry updated
Mar 6, 2015
Outcomes
What the study measures.
Primary outcomes
To evaluate the pharmacokinetics of Symlin in adolescent subjects with type 1 diabetes
Time frame · single doses
To assess the safety and tolerability of Symlin in adolescent subjects with type 1 diabetes
Time frame · single doses
Secondary outcomes
To evaluate the effects of Symlin compared to placebo in adolescent subjects with type 1 diabetes on various pharmacodynamic endpoints
Time frame · single doses
Eligibility
Who can take part.
- Minimum age
- 12 Years
- Maximum age
- 17 Years
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * Diagnosed with type 1 diabetes mellitus for at least 1 year prior to screening * Be on a stable regimen requiring multiple daily injections of basal and mealtime insulin or continuous subcutaneous insulin infusion for at least 2 weeks prior to screening * HbA1c between 6.0% and 10.0%, inclusive, at screening * Body weight \>=50 kg at screening Exclusion Criteria: * Currently being treated with the following medications: \*Any oral antihyperglycemic agent; \*Drugs that directly affect gastrointestinal motility * Has been previously treated with Symlin/pramlintide (or has participated in a Symlin/pramlintide clinical study) * Has received any investigational drug within 1 month of screening
Study locations
3 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Research Site
Aurora, Colorado, United States
Research Site
Kansas City, Missouri, United States
Research Site
New York, New York, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.